The present invention relates to a breast implant implantation method and apparatus used in the method.
More particularly, one aspect of the present invention relates to a method for implanting a breast implant into a subject, the method comprising: providing a sterile, flexible, elastic biodegradable bag sized to contain the breast implant; providing a sterile breast implant; inserting, using sterile handling, the sterile breast implant into the sterile bag to form a sterile breast implant assembly; closing the bag to fully enclose the implant within the bag; and implanting in a sterile manner the sterile breast implant assembly into the subject.
Another aspect of the invention relates to a sterile bag, which may be provided in a kit, and preferably is used with one embodiment of the method. The bag includes first and second chambers connected by a channel for moving a breast implant from the first chamber through the channel to the second chamber without directly touching the implant. An incision dilator may also be included with the kit or provided separately for use in a preferred embodiment of the method.
Preferably the bag is made of a sterile, drug-eluting biodegradable material that preferably contains at least one drug for reducing or preventing infection, inflammation, capsular contracture, scarring or other indication or complication associated with breast augmentation or breast reconstruction.
Breast enhancement is commonplace in society. More than 600,000 breast augmentation procedures are performed in the U.S each year. Common problems involving breast implants include implant infection and capsular contracture, among other things.
Another issue arising with the use of breast implants is the formation of excess scar tissue around an implant. Such tissue can harden and lead to tightening around or squeezing of the implant, a phenomenon known as capsular contracture. While scar tissue and capsule formation is a normal process, when scar tissue is excessive the subsequent capsule is called capsular contracture and can lead to an implant that is misshapen, painful, hard and can attain an unnatural appearance and feel. Additionally, capsular contracture appears to be more common following infection, hematoma and seroma.
The reasons for implant infection in the early post-operative period can include residual blood following surgery, direct contact with breast ducts (that have bacteria within their lumens) that have been injured during surgery or other surgical contaminants. Current treatment includes antibiotic washings of the surgical site and implants at the time of surgery and oral antibiotics after surgery.
Infection can occur anytime from several days to several years after implantation; however, it occurs more frequently in the immediate post-operative period. Acute infection is diagnosed when the patient exhibits pain, fever, and tenderness around the implant usually manifested within several days from the time of surgery.
The reason for capsular contracture is not well-defined. However, several different treatments have yielded improved results with less chance of capsular formation. First, leukotriene receptor antagonists, such as zafirlukast (Accolate®), montelukast (Singulair®), and pranlukast administered orally have demonstrated the ability to moderate the capsular contracture. Second, antibiotics surrounding the implant have anecdotally been a source of improvement in capsular contracture. Finally, textured implants have yielded a reduction in capsule formation, but are not desirable because of aesthetic issues.
Implant infection is most commonly attributed to contamination of the sterile field during surgery or to contamination arising from lymph node or mammary duct dissection during surgery. Bacteria can migrate deep within the breast tissue via the mammary ducts. Incision through the ducts during subglandular placement thus opens a temporary but direct external route for contamination of the implant after placement. Bacteria colonized from the mammary ducts and nipples is similar to exogenous flora found on the skin, namely coagulase negative Staphylococcus, P. acne, and Bacillus subtillus. 
Subclinical infection is perceived to be a contributor to capsular contracture. Subclinical infection is defined as bacterial colonization of a surface with or without biofilm formation. It does not produce the signs and symptoms traditionally associated with frank infection (such as pain, tenderness, fever, and pus) and manifests itself as a chronic inflammatory response. This inflammatory response leads to an overaggressive collagen deposition during tissue remodeling resulting in fibrous tissue buildup and capsule rigidity with eventual implant distortion.
Most surgeons engage in prophylactic efforts to reduce the incidence of infection associated with breast implants, including a no-touch technique by the surgeon. For example, in addition to meticulous attention to sterility, many surgeons irrigate the implant pocket and bathe the implant itself with gentamycin, cefazolin, povidone-iodine or another antibiotic solution. Post-operative counseling includes instructing the patient to neither touch the incision sites nor to immerse them in hot water for at least two weeks (or until healing is complete). Prophylactic oral antibiotics can also be given to patients prior to, during and after surgery to prevent post-implant colonization. Additionally, implant placement below the muscle avoids (or at least minimizes) surgical contact with the mammary ducts.
The present invention aids in the practice of no touch breast augmentation or reconstruction procedures by encasing the sterile implant in a sterile, biodegradable bag from which it does not have to be removed, such that the implant is not directly touched, but rather is implanted into the subject while encased in the bag, preferably made of a material containing at least one drug, such as one or more antibiotics or drugs useful in reducing or preventing infection and capsular contracture.
Adams and colleagues used a method for reducing capsular contracture caused by bacterial implant colonization. They provided an antibacterial irrigation solution and employed sterile technique prior to and during surgery. Adams' “triple antibiotic solution” originally contained a mixture of bacitracin, gentamycin, and cefazolin and was shown to be active against bacteria most commonly known to colonize breast implants. Adams subsequently published results of a six-year clinical study showing that patients who received surgeries incorporating these techniques have a 1% capsular contracture rate as opposed to national rates, which approached 15-20% in that same time period (Adams et al. (2006) Plast. Reconstr. Surg. 117:30-36).
Texturing the outside silicone surface has been employed as a technique to prevent capsular contracture. The textured surface causes a disorganization of collagen during deposition which minimizes capsule contracture. However, these implants have not significantly penetrated the market because, in use, tissue adherence to the textured surface leads to visible dimpling effect when the recipient moves. Textured implants also tend to have thicker shells than smooth implants and higher rupture rates.
The partial or total adhesion of the implant to the capsule due to such tissue ingrowth may be undesirable in the event it becomes necessary to remove or replace the implant. Notwithstanding the foregoing disadvantages, textured implants having a biocompatible, non-bioabsorbable outer tissue-contacting surface are generally considered to reduce the incidence of capsular contracture in patients.
There remains a need for an implantable filled breast prosthesis, referred to herein as a “breast implant,” typically filled with silicone gel or saline solution, with or without gas pockets, that resists infection and capsular contracture following implantation and that resists adherence of the implant to the capsule.
The sterile, biodegradable bag of the present invention, when used with breast implants, and the method of the present invention, overcome these drawbacks while reducing or preventing capsular contracture as well as treating or preventing infection, pain, inflammation, scarring or other indications or complications associated with breast augmentation or breast reconstruction.
As used herein, the singular forms “a”, “an”, and “the” include plural referents, and plural forms include the singular referent unless the context clearly dictates otherwise.
Certain terminology is used in the following description for convenience only and is not limiting. Words designating direction such as “bottom,” “top,” “front,” “back,” “left,” “right” and “sides” designate directions in the drawings to which reference is made, but are not limiting with respect to the orientation in which the bags, implant assemblies including bags or kits including them may be used. The terminology includes the words specifically mentioned above, derivatives thereof and words of similar import.